Makers of cough and cold medicines for very young children announced they are pulling the products from retail shelves, The New York Times is reporting. The news is certain to startle parents who have long used the drugs to quiet the coughs of young children.

It’s no great loss. There’s no real evidence that these cough medicines work, and it is clear that in kids the drugs can cause unpleasant side effects such as agitation and sleep problems. If you’ve just given your infant a dose of Pediacare or Triaminic, however, there’s no need to panic. The health concerns appear to arise from parents accidentally giving their kids the wrong doses, or from using different medicines containing the same active ingredients.

The move today affects only major brands labeled specifically for infants, but the Food and Drug Administration still plans to review whether any of the drugs should be used in children under the age of six. Many parents are convinced, against all evidence, that these medicines are safe and effective. But it’s worth noting that now both a Food and Drug Administration safety panel and the industry’s own trade group agree that the products shouldn’t be used in very young children. So what to do for your kids?

A child’s cough can result from a simple cold or from a number of health concerns, including reflux, asthma, sinus infections or allergies. Because cough in kids can mean so many different things, parents should discuss a child’s cough with a doctor. But if the cause isn’t anything severe, fluids and a humidifier in the room can help soothe the cough. (For more information about cough and kids, I recommend www.drgreene.com, the Web site of pediatrician Dr. Alan Greene.)

This cold and flu season, it seems likely most parents will be falling back on the traditional remedies: liquids, rest, chicken soup…and lots of comfort.

I find this pretty disappointing, actually. There’s really no reason to pull all of these medications off the market. The level of reporting and discussion in the recent media is sadly unsophisticated. I don’t know if that has contributed to this decision on the part of drug makers, but it can’t have helped.
The real risk of overdose appears to primarily come from the use of medications with multiple ingredients – if you mistakenly use more than one that has the same ingredient then the dosage of one or more ingredients is too high. I’m sure this happens to adults, too, though with less serious consequences, as the cogh & cold section of the pharmacy is filled with 100’s of permutations of the same 5 ingredients in different combinations and brand names.
So why not simply stop packaging these drugs with multiple ingredients? Then a parent could more carefully consider whether each ingredient is suited to their childs’ symptoms and the overdose risk would be greatly reduced.
Of all the ingredients commonly found in children’s cough and cold medications, only one has been questioned in terms of its effectiveness. That one is dextromothorphan, which has been claimed to quiet dry, unproductive coughs. Its efficacy has recently been questioned in adults as well as children, and this is definitely something the FDA should be looking into (personally, I don’t find it effective.)
The two decongestant ingredients, guaifenesin and pseudoepedrine (or the non-meth-ingredient substitute PE) are definitely useful in adults. Guaifenesin thins mucous making it easier to cough up or blow out. Pseudoepedrine helps reduce mucous production, though it can raise heart rate and cause restlessness in some people (but certainly not all). I don’t know if there are good medical studies showing these ingredients to be effective in children, but as a mom I am conviced they do help reduce congestion. I’ve used both of them with my infant son and I’m personally convinced they helped keep him out of the hospital when he had bacterial pneumonia and viral RSV.
(The other ingredients commonly found in cough & cold medications are aceteminophen and ibuprofen. The efficacy of these to reduce fever and ease pain has not been called into question.)
The main impact of this recall, in advance of an impending ban, is more crowded pediatrician’s offices. Now we’ll have to drag our kids into the doctor so they can get some relief from the common cold. What a ridiculous overreaction!

I think it’s funny how I keep reading, “There’s no real evidence they work.” I have evidence they work — I’ve given them to my kids, and sometimes they do work, and sometimes they don’t. Maybe it depends on what’s causing the cough? But only an idiot parent would keep on giving their kid medicine that never worked on the cough.

As a mother if two teenagers, and a childcare provider for 16 years, my opinion is that these products do not work. It is ok to have a cold, and it is nothing to see a doctor about. Most children recover nicely on their own in due time. People need to stop depending on these products. Slow down, let your child rest, drink plenty of fluids and get over it!

They are being dishonest. Some of the deaths of infants occurred when the infants were given these medications IN THE RECOMMENDED DOSES. It has nothing to do with misuse. These medications can kill a young infant with normal doses, because the immature infant liver is unable to metabolize them.

Just an honest question,
Why is it every time I’ve taken my 9month old son to get his shots his pediatrician makes sure to inform us we better make sure he’s given a dose of Tempra to avoid any fevers or anything else that may occur upon receiving his needle? When knowingly it may cause more injury then good?

I think it is good that they are taking the
product off the market. There are two many
young parents and foreign parents that are not
using the meds correctly. I think more emphasis should be on how to avoid the spread of illness within your home. That cloth towel that your neighbors, kids and everyone shares over and over
in your bathroom is one of the biggest sources
of germs. Put more emphasis on how to avoid the
illness. We found a great product called Healthy Shelf that we use in our home and I’ve noticed
we have fewer colds.

Parents/caregivers need to make sure they understand how to use medicines correctly. A lot of products that are otherwise safe for most people can become un-safe if the wrong dosage is given or the child has an allergy to it. A lot of cold medicines have acetaminophen already in them. If a parent/caregiver doesn’t realize this they may mistakenly give another dose of acetaminophen/tylenol separately and not realize they have just overdosed the child. A Pharmacist, Doctor or Nurse should be able to help. A lot of medicines don’t have instructions for kids below two years of age and just because a baby is two doesn’t mean he/she is more than 24 pounds so the medicine may have to be adjusted. As a result of the diversity of this country, it would be very helpful for companies to provide instructions in at least English and Spanish. Of course it’s preferable and also smart to use common sense and learn the language. However, kids shouldn’t have to suffer. The Pharmacy can also help with this. Use a picture of a medicine dropper, syringe (without the needle) or medicine cup so there isn’t confusion where you can list the correct dosage for different weights. (Some companies already do this) It might help for some of the hospitals to offer a free class on how to correctly administer medication to people who need extra help. Some medications might have a bad interacton with another medication as well or bad side effects. Hopefully this issue will get resolved soon. Even shampoo can be dangerous if somebody uses it the wrong way.

If any of these medicines are safe and effective, a marketer/manufacturer can run the clinical studies to show they are safe and effective. Then they can sell them again. Expensive, but if the product is safe and effective, the expense is clearly worth it in terms of future profits. The burden of proof is properly placed upon the company that is marketing and manufacturing a product. Clearly, some of the current products are not safe and effective. The number I saw in the news was that in the U.S. ~ 50 babies a year die from these medicines, and that # is probably low due to underreporting. If 50 die, 100’s or 1000’s have serious consequences with lifetime negative effects.

A number(s) I have not seen is how many babies will die each year because these products are not on the market, and how many babies will have serious consequences with lifetime negative effects because these products are not on the market. I’m not into working cost-benefit ratios with babies’ lives, but I would think that the positive requirement would have to be several thousand lives saved and tens of thousands of serious consequences eliminated. I cannot imagine that the above would be the case.

I don’t know, I’m not a doctor, but what does effective mean? Does it mean that it lessens a cough? Or does it mean that a baby who would have died instead lived, or that a baby who would have had lifetime negative effects instead remained completely healthy?

Having worked in the pharmaceutical industry for 20 years, much of it in the consumer health division of the industry, it is my professional opinion that there are a lot of good products out there and a lot of bad products out there. Both the good and bad products are driven by the marketer’s and manufacturer’s need to make a profit, and I am 100% certain that profit is a bigger driver (not the only driver) than safety and effectiveness. Not to say that a highly unsafe medicine will not be removed, but I can guarantee that a profitable product will stay on the market if it is ineffective and has some safety problems.

Time will tell if the products pulled today are such a case, being profitable, ineffective, and with some safety problems. I think that products aimed at children need to be especially scrutinized, since children are thoroughly incapable of performing a cost-benefit analysis themselves. Marketers and manufacturers can be guaranteed to not perform that scrutiny, so as Americans we must require our government, in this case the FDA, to perform that analysis of safety and effectiveness.

It is my understanding that the medicataions that are being withdrawn from the shelf are the cold medications not the pain and fever medications, if this is correct, then is it still safe to give our babies the Tylenol or Motrin for teething pain or to reduce the side effects of immunizations.

I don’t think they are pulling fever medications, like plain Tylenol and Motrin. They are pulling ones with multiple meds in them that have other meds like with decongestants and antihistamines in addition to the fever reducers in them.

For Lisa:
Tempra is a brand name for acetaminophen. Acetaminophen is not one of the coud and cold medications being pulled from the shelves. It is a pain reliever and fever reducer. Shots always hurt and sometimes cause fevers. So it is OK to give. If you dno t know what you are giving then ask your pediatrician! (or read the label and look it up).

FOr everyone else:
Parents rarely know what over-the-counter medication they are giving their child. They rarely know the name, the ingredient or the dose. They do not realize that different formulations contain different medications, and they do not realize that different brands and different formulations may have the same medications at different concentrations. Medicines are dosed based upon the kid’s weight and must be calculated for each child. This is why your doctor asks specifically: “what are you giving your child”? It is hard to hear “robitussin” because that is a brand name – it does not tell her the active ingredients. It is difficult for her to tell you how much to take, because she has to know how many milligrams of the med is in each teaspoon or mL of the product you have at home.

And: there is not scientific evidence – that is there are no randomized conterolled trials — that these mediacations work. THe commercials are good, though.

I would also like some straight information as to why these products are being pulled. Is it overdosing by people who are confused by the proper dosages or who give multiple doses of different products with the same ingredients? Or are this products unsafe at recommended doses? I don’t think this has been clearly stated.

I have also found the prevalence of combo products very frustrating. As an adult, I don’t like to take combo products–I prefer to take each one separately (I read labels carefully and take note of all active ingredients). I don’t want to take aceteminophen with my decongestant; and I know I’ve read that there have been cases where adults have suffered serious liver damage from taking combo products and then additional straight aceteminophen because they didn’t realize that the same active ingredients were in both products. So if the problem is overdosing from giving multiple combo products, let’s eliminate the combo products and offer the decongestants without the pain reliever. I am reluctant, though, to give my child anything with pseudoephedrine in it–it makes *me* feel hyper and interferes with my sleep; I generally only take it when desperately stuffed up, and even then I try to limit to daytime use. But it *does* work–I just don’t enjoy the side effects.

What is the status of OTC allergy medications for children like Children’s Benedryl and Children’s Claritin? Both seem effective for my preschooler, and they don’t seem to have pulled.

Some people have commented that maybe the reason they are pulling infants cold medications from the shelves is to have parents go to a doctor first before getting medication. Sometimes this is okay but some parents who are very knowledgeable about their infant by researching what is best for their infant can understand what medication would help with a cold. Orange juice is a good source of Vitamin C and many parents have their infants drink this during times of the cold / cough season. There are several other sources of food / juices which helps to avert colds.

It is very important to think about infants who are in possible dengerous if they intake those medications. But it is very confusing to give medications to sick child if they are not effective. That makes parents more worried than it used to be. Why responsible people didn’t think about those medicines in the first place before they come in market.

As a pediatrician and a mom I understand where a lot of the frustration stems from. Most parents just want a clear answer. If all of a sudden these OTC meds aren’t safe then why the withdrawal now?

The questionable safety of these OTC meds have been around for many years. Just now are the manufacturers catching up with the current recommendations which are no OTC meds for infants under the age of two. It’s what the American Academy of Pediatrics has been recommending since January and something that most pediatricians should be passing along to their parents.

If you look at the CDC Morbidity and Mortality Weekly report back in January of 2007 you’ll find that they investigated the deaths of three infants. Their deaths were determined to have stemmed from OTC cold medication. You can view the report at //www.cdc.gov/mmwr/preview/mmwrhtml/mm5601a1.htm

BTW There is no “recommended” dosage for infants put forth by the FDA. There are clear instructions on the boxes to consult a doctor if the child is under two years of age.

As recently as last year I was recommending the OTC infant drops as well as giving them to my children. After January 2007 I changed my stance and have been telling my parents what research has found and telling them what I recommend and then they make their own choice. Well now the choice is out of their hands. At least until we have more information and to tell you the truth that’s fine with me.

Most kids will do well with plenty of fluids, rest, nasal bulb suction and maybe a humidifier. I don’t mind seeing extra patients in my office and will certainly answer questions over the phone. Any good pediatrician should tell you the same.

Withdrawl of infant cold meds is no loss because these drugs had potential
for harm. I have felt nervous for years about these products since one patients parents told me that their child had halucinated after taking an antihistamine-decongestant combination. The child had to be hospitalized overnight after becoming hysterical because the “bugs were crawling all over.” This was a 5 year old.
Usually plain acetaminophen or ibuprofen will help a sore throat and irritated nasal passages enough so that a child and parent will sleep and get better. Thats all that is needed but these also have side effects so exercise caution.

This goes to: a little knowledge is a dangerous thing. Or MISuse of entities.

Luckily, the stupidity of us all hasnt gotten so bad that plastic bags have been withdrawn as well. Most of these products are marketed to children, not infants and toddlers. The difficulty is that the average person does not differentiate anyone under the age of, say 12, as anything other than a child. A medical doctor (allopathic or osteopathic) will tell you that there is a significant difference in a 1)Neonate (1st month of life, or until a certain size) 2)Infant (basically until age 2 during which immune system is still developing, as are the nervous system, etc etc) 3) toddler (development of motor skills) 4)child (development of social, mental skills with continued physical growth). Each age has it’s difference in metabolism and response to agents (foods, pharmaceuticals)

Unfortunately, without the sage advice of grandmothers and limited accessibility to doctors (time, money, esp the former), these differences ar lost on most.

Additionally, many of the pharmaceuticals included in those products have not been statistically proven – that means they are more likely to have the desired, beneficial effect in the average person of appropriate characteristics than chance. What engendered action now is a reassessment (which has been ongoing by the American Academy of Pediatrics) for potential of harm (viz, death) versus benefits. [Vioxx, similarly, was felt to have greater risk of harm than benefit, especially in light of other agents available. Thus far, Avandia still has a greater benefit than risk for harm. Note that both of these are more restricted in access – requires prescription from a licensed physician, with counseling by the pharmacist at time of dispensing. – but way too many dispense with the latter.)

#2 wrote:
>I think it’s funny how I keep reading, “There’s no real evidence they work.” I have evidence they work — I’ve given them to my kids, and sometimes they do work, and sometimes they don’t.

But in a clinical sense, that isn’t evidence. I think you’ll find the same is true if you gave your kids a pacebo. Sometimes their symptoms will get better without any medicine at all. The placebo can’t be said to “work.”

Infant droppers are imprecise; manufacturers know this, and provide dosing instructions accordingly. Isn’t there a pretty wide safety margin built right in there? If the margin for error is narrow enough to cause widespread, honest confusion and misuse, then go ahead and pull these products… but somehow, I doubt it.

While products for infants merit extra caution, for every safeguard there will always be a subset of the population clever enough to outwit the system and injure themselves. In the absence of cold remedies for Infants, who will reach for the Children’s cough and cold section of the pharmacy, putting their infants at even more risk? Or stockpile what they can acquire now and dole it out long past the expiration date?

For crying out loud, read the friggin label. If you can’t read or don’t what the ingrediants are or do, ask the phamacist. Say, you’ve got a little child there, it might be a good idea to be careful. Good grief!

I’m sorry, but Ms. Daniels’ many points are mistaken or not on point. The problem with cough suppressants and children is that the medicines suppress the body’s natural defense mechanism, the cough, thereby almost guaranteeing that a simple cold will turn into pneumonia because of the build-up of fluid in the lungs. She even notes that her child had pneumonia. Children should never be given cough suppressants unless a pediatrician specifically advises to (which they will not, because they know the dangers). My point cannot be made emphatically enough.

Continuing my previous post. I found plain sudafed worked the best. I have to wonder how many parents on the FDA advisory panel haved tried to suction a baby’s nose – not always easy. Most kids do not want to eat when they are sick either – feed them chicken noodle soup? I agree combination medicines are to blame for overdoses. Let’s keep one medicine ingredient per bottle. I have the hardest time finding plain sudafed for my asthamtic daughter, who cannot have the cough medicines! I find this absolutely ridiculous.